MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-23 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Becton, Dickinson.
[18540407]
Customer called to report an incident that occurred while collecting a vaginal sample from a patient using the affirm atts sample collection kit. As they were removing the collection swab from the patient they noted that the cotton tip at the end of the swab was missing. They were unable to locate the cotton tip and provided the patient with antibiotics as a precaution.
Patient Sequence No: 1, Text Type: D, B5
[18866000]
The affirm atts collection kit is used to stabilize the nucleic acid of candida species, gardnerella vaginalis, and trichomonas vaginalis during specimen transport at ambient temperature (15-30 c) or (2-8 c) for up to 72h. Bd quality was unable to confirm this complaint due to the unknown lot and no return materials for investigation. A completed review of past complaints for this product as well as internal quality notifications found no trends for this issue. Bd quality will continue to monitor complaints for this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00010 |
| MDR Report Key | 3815481 |
| Report Source | 05 |
| Date Received | 2014-04-23 |
| Date of Report | 2014-04-03 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-03-27 |
| Date Added to Maude | 2014-06-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLODIO #579 NOGALES |
| Manufacturer City | SONORA, C.P. 84000 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT |
| Generic Name | LIO |
| Product Code | LIO |
| Date Received | 2014-04-23 |
| Catalog Number | 446255 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON |
| Manufacturer Address | NOGALES SONORA, C.P. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-23 |